Multi-lead multi-electrode management system

ABSTRACT

A multi-lead multi-electrode system and method of manufacturing the multi-lead multi-electrode system includes a multi-electrode lead that may be used to deploy multiple separable electrodes to different spaced apart contact sites, such as nerve or muscle tissues, for example, that are spatially distributed over a large area.

RELATED APPLICATIONS

This application is a continuation of and claims priority from U.S.patent application Ser. No. 14/073,117, filed on Nov. 6, 2013, which isa non-provisional application that claims priority benefit of U.S.Provisional Patent Application No. 61/793,084, which was filed Mar. 15,2013, of U.S. Provisional Patent Application No. 61/724,690, which wasfiled Nov. 9, 2012, and of U.S. Provisional Patent Application No.61/723,368, filed Nov. 7, 2012. The entire specifications of each ofU.S. patent application Ser. Nos. 14/073,117, 61/793,084, 61/724,690,and 61/723,368 are hereby incorporated by reference herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

This invention was made with government support under Award or ContractNo. N66001-12-C-4195 awarded by the Defense Advanced Research ProjectsAgency. The government may have certain rights in the invention.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to a multi-lead multi-electrodesystem having multiple separable electrodes, methods, and componentsrelated thereto.

BACKGROUND

In the past decade, there have been significant advances in developmentof neurotechnology to stimulate neural and muscle tissue to replace lostfunction due to neurological disability or neutoruma. For example, thereare commercially available systems for deep brain stimulation to treatsymptoms of Parkinson's disease and other neuromotor andneuropsychological diseases; vagal nerve stimulation for treating sometypes if intractable epilepsies and depression, gastric stimulation forgastroparesis, stimulation of the peroneal nerve for foot drop, sacralnerve stimulation for urinary urge incontinence and incontinence, pacingof respiratory and abdominal muscles for respiratory insufficiency, andtreatment of unmanageable and pathological pain in various sites of thebody.

Most often, a single lead is used to target a single stimulation site,for example for vagal nerve stimulation. Here, there is a singleelectrode contact site connected via the lead to a stimulating device.In some instances a single lead contains multiple electrode contacts inconcentric circles along its longitudinal axis placed at apre-determined distances. Such a lead is used to stimulate close butlongitudinally spatially separated excitable neural tissue, for example,for deep brain stimulation for treating Parkinson's disease spinal cordstimulation for pain management and inner ear (cochlear) stimulation fortreating hearing loss. Since, in all of the above multi-electrode leadconfigurations the contacts are placed on an inseparable substrate at apredetermined distance, they cannot be used for stimulating multiplesites that are spatially distributed over a large 2-dimensional areasuch as for gastric stimulation.

Additionally, for some functional outcomes, multiple nerve or muscletissues may have to be stimulated in a coordinated manner to achieve thebest functional outcome. For example, for restoring respiration in highquadriplegic subjects and in other respiratory disorders, along withphrenic nerve multiple muscles that are spatially distributed need to bestimulated. In gastroparesis and in other gastric disorders, spatiallydistributed muscles and nerve endings need to be stimulated and/theiractivity needs to be sensed.

In addition, there have been attempts to provide sensory feedback toupper extremity amputees by stimulation of the peripheral nerves. Suchperipheral nerve stimulation will also require multiple nerves to betargeted to provide information about multiple sensory sources andmodalities to the amputee. In order to develop the next generation ofneural driven prostheses for amputees, it will also be necessary torecord multiple motor intents by recording from different sites, forexample different peripheral nerves or muscle tissues. Some specificexamples are discussed briefly hereinafter.

MedImplant Patent OS-PS330342, from September 1976, shows a system witha coiled lead of multiple connecting elements partially encased and theneach individual connecting element is left free. Each individualconnecting element is coiled. No protective bundling method is revealed.

U.S. Pat. No. 7,983,755 shows multisite gastric stimulation withmultiple leads (Fig #4). However, U.S. Pat. No. 7,983,755 does notpresent a method for packaging such leads.

U.S. Pat. No. 5,690,691 shows multisite gastric stimulation withmultiple lead. However, U.S. Pat. No. 5,690,691 does not present amethod for packaging such leads.

U.S. Pat. No. 7,967,817 refers to a multi-electrode lead containingmultiple electrode contacts in concentric circles along its longitudinalaxis placed at a pre-determined distances.

U.S. Pat. No. 6,505,075 is an example for peripheral nerve stimulationto treat pain using longitudinal circular multi-contact lead.

U.S. Pat. No. 3,699,956 describes a percutaneous lead that providesfixation and minimizes bacterial penetration.

U.S. Patent Application Publication No. 2007/0255369 describes apercutaneous lead with flaps acting as anchors.

U.S. Pat. No. 4,934,368 describes two nerve cuff electrodes as aseparate leads.

There is a need for a multi-electrode lead with separable electrodecontacts to target nerve or muscle tissues that are spatiallydistributed over a large area.

SUMMARY

According to some aspects of the present disclosure, a multi-electrodelead and/or a packaging system for such a multi-electrode lead includesany one or more of the components described herein.

According to some aspects of the present disclosure, a multi-leadmulti-electrode system includes any one or more of the componentsdescribed herein.

According to some aspects of the present disclosure, a method offabricating a multi-electrode lead includes any one or more of thefabrication steps described herein.

Additional optional aspects and forms are disclosed, which may bearranged in any functionally appropriate manner, either alone or in anyfunctionally viable combination, consistent with the teachings of thedisclosure. These and other aspects and advantages will become apparentupon consideration of the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a multi-electrode lead with one or more electrodes onone end, a stimulating or recording device on the other end, and one ormore connecting elements.

FIG. 2 illustrates a coiled portion of the multi-electrode leadensheathed in a coil sheath along with electrodes, a stimulating orrecording device, and connecting elements.

FIG. 3 illustrates individual connecting elements ensheathed separatelyby individual protective sheaths along with connecting elements.

FIG. 4 illustrates individual ensheathed connecting elements encased inan end sheath.

FIG. 5 illustrates a protective outer sheath that overlaps the coilsheath on one end of the multi-electrode lead and extends beyond the endsheath on the other end, the outer sheath being secured withcircumferential sutures.

FIG. 6 illustrates a protective outer sheath that overlaps the coilsheath on one end of the multi-electrode lead and extends beyond the endsheath on the other end, the outer sheath being secured with runningsutures.

FIG. 7 illustrates flap like structures attached to the coil sheath.

FIG. 8 illustrates use of the flap like structures, the flap likestructures being spread open after insertion, thereby providing abarrier for exteriorizing of the lead through the skin.

FIG. 9 illustrates one example embodiment of a multi-leadmulti-electrode management system, where connecting elements arelongitudinal intrafascicular electrodes (LIFE) and multiplemulti-electrode leads are connected to an external connector and to animplantable pacemaker.

FIG. 10 illustrates a method steps for fabricating a multi-electrodelead.

FIG. 11 illustrates a prototype of distributed intrafascicularmulti-electrode (DIME) system.

FIG. 12 illustrates the outer sheath of FIG. 5.

FIG. 13 illustrates the coil sheath.

FIG. 14 illustrates a flap arranged in the form of a petal anchor.

FIG. 15 illustrates a fully assembled coil sheath.

FIG. 16 illustrates the multi-electrode lead with the petal anchor ofFIG. 14.

FIG. 17 illustrates an individual protective sheath along with proximaland distal apertures.

FIG. 18 illustrates dimensions for one exemplary embodiment of thesystem of FIG. 1.

FIG. 19 illustrates dimensions for one exemplary embodiment of thesystem of FIG. 5.

DETAILED DESCRIPTION

This disclosure describes a multi-lead multi-electrode system that maybe used to deploy multiple separable electrodes (contact sites) todifferent nerve or muscle tissues, for example, nerve or muscle tissuesthat are spatially distributed over a large area, and a process forpackaging such a system.

A multi-electrode lead is defined as a longitudinal structure that canlink a plurality of sensing or stimulating elements (electrodes) at itsdistal end to a stimulating or recording device or devices at itsproximal end using connecting elements. Examples of connecting elementsinclude metal wires that conduct electrical signals, ribbon cables thatconnect to an array of electrodes, optical fibers that conduct light,and similar devices. Preferably, the multi-electrode lead could be usedas a lead across the skin connected to an external connector or deviceor as an implantable lead that connects to an implantable device.

Turning now to the drawings, FIGS. 1-8 illustrate a packaging system fora single multi-electrode lead. FIG. 1 illustrates a multi-electrode lead12 with electrodes 1 on one end, or distal end, a stimulating orrecording device 2 on the other end, or proximal end, and elongateconnecting elements 3, such as wires and/or fiber optic strands,extending between the one end and the other end. The connecting elements3 are coated with a thin film of biocompatible material that insulatesit from the body fluids. The connecting elements 3 are secured togetherin a bundle between the proximal and distal ends. The bundle ofconnecting elements may be coiled over a partial length to providestrain relief and allow flexibility to the multi-electrode lead. In someinstances this coiling may not be present. In some instances, connectingelements 3 outside the coil sheath 4 may individually be coiled. Theelectrodes 1 and the distal ends of the connecting elements 3 areseparated or readily separable, i.e., not bundled or connected togetheror easily and readily separable such as along a frangible section orremovable temporary connection, such that the electrodes may be placedon or in a patient in a spaced apart array to be operatively engagedwith a plurality of spaced apart nerve or muscle tissues that arespatially distributed over a large area, such as to span multiple organsand/or muscle groups and/or nerve regions.

FIG. 2 illustrates the coiled portion of the multi-electrode lead 12ensheathed, i.e., sheathed within, such as by being surrounded and atleast partly encased within a sheath or casing, in a coil sheath 4. Thecoil sheath 4 is preferably formed of a tube of biocompatible material.The ensheathing element (e.g., the coil sheath 4) may extend beyond thecoiled portion. The coil sheath keeps the coiled bundle in place.

FIG. 3 illustrates individual connecting elements ensheathed separatelyby individual protective sheaths 5. Each protective sheath 5 ispreferably formed of a tube of biocompatible material. This ensheathingof individual connecting elements 3 permits separation of individualelectrode contacts. The length of the connecting elements 3 may bevaried. The individual ensheathing tubes (e.g., the protective sheaths5) extend beyond the electrode so that the terminal ends can be bundledtogether with an end sheath 6 as illustrated in FIG. 4. The end sheath 6is preferably formed of a tube of biocompatible material. The end sheath6 preferably forms a snug fit around all of the individual ensheathedconnecting elements 3. The end sheath 6 preferably allows the individualconnecting elements 3 to remain in a single manageable bundle.

FIG. 5 illustrates a protective biocompatible tube forming an outersheath 7 that overlaps the coil sheath 4 on one end of themulti-electrode lead 12 and extends beyond the end sheath 6 on the otherend. This outer sheath 7 is preferably a slit tube that allows insertionof the multiple ensheathed connecting elements 3. The outer sheath 7 maybe closed using different methods. One method is to use circumferentialsutures 8 applied over the end sheath 6 and the coil sheath 4 portionsof the lead 12 such that direct compression force is not applied to theindividual connecting elements 3. Another method, which is illustratedin FIG. 6, is to use a continuous run threaded suture 9, which may bealigned longitudinally along the bundle, and which may be easilyunraveled during surgery.

FIG. 7 illustrates flap like structures, such as flaps 10, that areattached to the coil sheath 4. These flaps 10 may be made ofbiocompatible material, such as silicone, and may be pre-attached to thecoil sheath 4 either during the process of making the coil sheath 4 tubeor with a medical adhesive. The flaps 10 are pliable and preferablyapproximately 300 to 500 microns in thickness allowing them to be easilybent. These flaps 10 can be sutured to fascia or other tissue through ornear which the lead 12 is being tunneled to anchor the lead. Forpercutaneous leads, the flaps 10 may be positioned on the portion of thelead adjacent to the inner surface of the skin. On insertion of the lead12, the flaps 10 may be spread by the inner surface of the skin, asillustrated in FIG. 8, thereby providing a barrier for exteriorizing ofthe lead 12 through the skin 11. The flaps 10 also provide a barrier formigration of external infectious agents into the body. The flaps 10 canbe coated with antibacterial, anti-inflammatory agents during the leadinsertion process.

As illustrated in FIGS. 9A and 9B, multiple such multi-electrode leads12 can be prepared with their proximal ends connected to a singledevice, such as an external connector 13 or an implantable pacemaker 14.

For deployment, individual multi-electrode leads 12 are routed to thevicinity of the target site for the electrode contact. The sutures 8and/or 9 securing the outer sheath 7 are removed and the individualconnecting elements 3 with their protective sheaths 5 and end sheath 6are lifted along the slit portion of the outer sheath 7, which isdiscarded. Each individual connecting element 3 may be removed from theend sheath 6 as needed. The individual protective sheath 5 from theconnecting element 3 is removed and the electrode 1, electrode array, ordistal end is anchored to and/or inserted into the targeted tissue.

In one embodiment, a multi-lead multi-electrode system including one ormore of the multi-electrode leads 12 may be used for recordingperipheral nerve motor activity from multiple nerves at multiple sitesusing longitudinal intrafascicular electrodes. In such a distributedintrafascicular multi-electrode (DIME) system, there may be multipleleads targeting multiple nerves, where each multi-electrode lead is madeup of 6 connecting elements. The connecting element consists of a Pt—Ir(90-10) wire of 25.4 μm diameter coated with biocompatible PTFE materialof 7.6 μm thickness. Each Pt—Ir wire may be encased in a protectivesheath consisting of a biocompatible polyimide tube of 160 microns innerand 179 micron outer diameter. Six such elements may be encased in anend sheath formed of a biocompatible silicone tube of 508 micron innerdiameter and 940 micron outer diameter. The coil sheath formed of abiocompatible silicone tube has inner and outer diameters of 300 and 600microns, respectively. The outer sheath formed of a biocompatiblesilicone tube has a 1400 microns inner diameter and 2000 microns outerdiameter.

FIG. 10 illustrates method steps for a typical process of fabricatingthe lead 12. At 30, elements 3 are prepared for connecting to the lead12. At 31, the connecting elements 3 are coiled and inserted into thecoil sheath 4. At 32, the active electrode contacts 1 are created. At33, the connecting elements 3 and the active electrode contacts 1outside of the coil sheath 4 are inserted into the protective sheath 5.At 34, all of the protective sheaths 5 are bundled together and insertedinto the end sheath 6. At 35, the entire bundle, from the coil end tothe end sheath 6, is inserted into the outer sheath 7. At 36, the outersheath 7 is closed, for example, with the suture 8 and/or 9. At 37, theproximal end is connected to an operative device 14, such as a recordingdevice or a stimulating device, or to a connector that connects to suchan operative device.

FIG. 11 illustrates one preferred embodiment of a multi-leadmulti-electrode management system constructed in accordance with theteachings of this disclosure. In this arrangement, a separate groundelectrode 25 that is not part of the packaged lead 12 is alsoillustrated. At least one, and preferably more than one of themulti-electrode leads 12 are connected to the operative device 24.Further, the ground electrode 25 is operatively connected with one ormore of the multi-electrode leads 12. However, a multi-leadmulti-electrode management system is not limited to the components shownin FIG. 11, and may include additional components or fewer components.

As illustrated in FIG. 12, the outer sheath 7 of FIG. 5 may be preparedby first making a transverse cut 14 at the proximal end and subsequentlyslitting the outer sheath longitudinally along its length 15.

As illustrated in FIG. 13, the coil sheath 4 may have an anchoringstructure 17 at its distal end. The anchoring structure 17 serves tohold the suture 8 or 9 securing the outer sheath 7 to coil sheath 4 inplace. In the illustrated embodiment, the anchoring structure 17 has an“arrow head” shape including a raised circumferential “ridge” likestructure with a conical tip. The ridge structure is preferably formedby patterning silicone on top of the coil sheath.

FIG. 14 illustrates one exemplary arrangement of the flaps 10 of FIGS. 7and 8, the flaps 10 having the form of a petal anchor 19. The petalanchor 19 can be fabricated using any flexible tube like structure,preferably made out of biocompatible material. In one embodiment, thepetal anchor 19 is fabricated using a silicone tube as illustrated inFIG. 14. One end of the tube is split into 3 or more parts of desiredlength along its length to form multiple petal like structures 18extending from a base portion 20. The parts 18 are preferably equallysized. The petal base 20 can be reinforced by adding an additional layerof silicone.

FIG. 15 illustrates a fully assembled coil sheath 4 with a “ridge” likestructure 17 at the distal end, and the petal anchor 19 at the proximalend. During percutaneous implantation, for example into a human patient,the petal like structures 18 the petal anchor 19 open up once the coilsheath 4 is pushed across the skin 11, as illustrated in FIG. 16. Onceopen, the anchor 19 serves to reduce the in-out movement of the leadinto and/or out of the patient, thereby minimizing the chance ofinfection due to “pistoning” effect. The petal anchor 19 also provides abarrier for exteriorizing of the lead 12 through the skin 11.

FIG. 17 illustrates an individual protective sheath 5 along withproximal 1704 and distal 1706 apertures. As previously illustrated inFIG. 3, individual connecting elements 3 may each be ensheathed byindividual protective sheaths 5 that may comprise a tube ofbiocompatible material. Sterilization of connecting elements 3 isrequired in order to introduce them in a human body and is achieved byadequate penetration of a sterilization agent into the space between theprotective sheath 5 and connecting elements 3. As illustrated in FIG.17, in order to allow the sterilization agent to reach the connectingelements 3, apertures 1704, 1706 are introduced to the protectivesheathes 5.

Apertures 1704, 1706 may be distributed along the entire length of theprotective sheath 5 or over defined lengths of the protective sheath 5.In one embodiment, the protective sheaths 5 are manufactured of abiocompatible polyimide tube of approximately 160 microns inner and 170microns outer diameter and the length of the tube 5 is approximately 150millimeters. Apertures 1704, 1706 may be laser drilled for the firstquarter or proximal end, and last quarter or distal end, of theprotective sheath 5, covering approximately 4.5% of the surface area ofthe protective sheath 5. In this embodiment, there are no apertures inthe middle portion of the sheath 5.

In one embodiment, a total of 12,000 apertures 1704, 1706 may bedrilled, 600 on each end of the protective sheath 5. In one straightline at the proximal and distal ends, 1500 apertures of approximately 15μm diameter are drilled with 50 μm distance between the apertures. Thispattern may be repeated around the circumference of the tubing atapproximately 45 degrees for a total of 8 lines of apertures along thelength of the protective sheath 5. The apertures 1704, 1706 facilitatepenetration of the sterilization agent from either end of the protectivesheath 5 and allow sufficient diffusion of the sterilization agent tothe middle half of the sheath 5. The solid surface of the centralportion of the sheath 5 (e.g., the section without apertures) offersstiffness and improves the manipulation and management of the individualhighly flexible connecting elements 3 inserted into the protectivesheath 5 during deployment and implantation.

FIG. 18 illustrates approximate dimensions in centimeters (cm) for oneembodiment of the system illustrated in FIG. 1, while FIG. 19illustrates approximate dimensions for one embodiment of the systemillustrated in FIG. 5. Other dimensions may be used depending on theparticular application involved.

In other exemplary arrangements, connecting elements 3 may be microfiber-optic cables for optical stimulation connected to different typesof electrodes, such as thin film longitudinal intrafascicular electrodes(tfLIFE), transverse intrafascicular multichannel electrodes (TIME),flat interfaced nerve electrodes (FINE), and other electrodeconfigurations or combinations of two different electrode configurationsas would be well understood in the art.

A multi-electrode lead, multi-lead multi-electrode management system,and/or method of making a multi-electrode lead in accordance with theteachings of the present disclosure may be useful in one or more ways,including but not limited to:

-   -   1. Multi-site gastric muscle/enteric nerve stimulation,        recording and simultaneous stimulation and recording for        treatment of gastroparesis, obesity, dysmotility and other        gastric disorders;    -   2. Multi-site stimulation of peripheral, cranial and spinal        nerves for pain management;    -   3. Multi-site stimulation of peripheral nerves for sensory        feedback from prostheses or other external device with sensing        elements;    -   4. Multi-site recording from peripheral nerves for identifying        multiple motor intents for potential use in control of        prostheses;    -   5. Multi-site stimulation of multiple muscles, such as        intercostal muscles, abdominal muscles and diaphragm for        respiratory assistance;    -   6. Multi-site stimulation of phrenic nerves (left and right) for        phrenic pacing for respiratory assistance;    -   7. Multi-site stimulation of nerves for functional electrical        stimulation after paralysis for activities such as hand grasp,        pinch, standing, walking;    -   8. Multi-site recording from multiple muscles using implanted        electrodes for control of prostheses;    -   9. Multi-site recording and/or stimulation of nerve or muscle        tissue involved in the control of bladder and/or bowel function;        and    -   10. Multi-site recording and/or stimulation of nerve or muscle        tissue involved in the control of the spleen or other organs        involved in the immune system or other systems that are        innervated by autonomic nervous system tissue.

The multi-electrode lead, multi-lead multi-electrode management system,and/or method of making a multi-electrode lead of the present disclosurein some arrangements may provide solutions for various practical hurdlesposed by the commercially available multi-electrode leads. For example,current commercially available multi-electrode leads are typically asingle macro lead that connects to electrode contacts that are evenlyplaced in concentric circles. This type of configuration of lead is notpossible to implant in micro structures such as peripheral or cranialnerves or implanting in soft movable structures such as gastric muscles.The proposed packaging process for multi-electrode systems of thepresent disclosure, however, would facilitate in some arrangementstargeting peripheral or cranial nerves, gastric and other nerve ormuscle tissues that are spatially distributed over a large area or spanvarious organs.

In another example, in commercially available multi-electrode leads, theinter-electrode distance is pre-determined. Intraoperatively, the onlyway the inter-electrode distance can be changed is by choosing differentpairs of electrodes. In the proposed multi-electrode lead configurationof the present disclosure, however, there is in some arrangements fullflexibility of specifying the intra-electrode distance at the time ofimplantation.

In a further example, packaging according to the teachings of thepresent disclosure in some arrangements can prevent or minimizeentanglement of individual connecting elements.

Additionally, packaging according to the teachings of the presentdisclosure in some arrangements allows management of the lead andconnecting elements during a surgical procedure.

We claim:
 1. A multi-electrode lead comprising: a plurality ofelectrodes; a plurality of elongate connecting elements, each connectingelement having a distal end and a proximal end, the distal end of eachconnecting element being operatively connected to one of the pluralityof electrodes and separate connecting elements being operativelyconnected to different electrodes, at least two of the connectingelements being secured together in a bundle between the distal andproximal ends; and a coil sheath, the bundle being ensheathed in thecoil sheath, wherein the electrodes and the distal ends of theconnecting elements are separated or readily separable such that theelectrodes are adapted to be applied to a plurality of different nerveand/or muscle tissues spaced apart across a region where multiplemuscles or multiple nerves interact on a patient, and wherein the bundleof elongate connecting elements is coiled over a partial length thereofwithin the coil sheath to provide strain relief and to provideflexibility.
 2. The multi-electrode lead of claim 1, further comprisinga plurality of protective sheaths, wherein each connecting element isensheathed separately by at least one of the protective sheaths.
 3. Themulti-electrode lead of claim 2, wherein each of the plurality ofprotective sheaths comprise a tube including a plurality of apertures.4. The multi-electrode lead of claim 1, further comprising an outersheath, wherein the outer sheath encases a portion of the connectingelements and the electrodes, and optionally wherein the outer sheathincludes a first end that overlaps the coil sheath and a second end thatextends beyond the end sheath.
 5. The multi-electrode lead of claim 4,wherein the outer sheath is in the form of slit tube.
 6. Themulti-electrode lead of claim 5, wherein the slit tube comprises anelongate tube having an axis extending from a first end to a second enda longitudinal slit extending from the first end to the second end. 7.The multi-electrode lead of claim 5, wherein the slit tube is closedaround the connecting elements with one of a circumferential suture anda continuous run longitudinal suture.
 8. The multi-electrode lead ofclaim 1, further comprising one or more flaps attached to the coilsheath.
 9. The multi-electrode lead of claim 8, wherein the flaps arepliable and disposed adjacent the proximal ends of the connectingelements.
 10. The multi-electrode lead of claim 8, wherein the flaps arecoated with antibacterial and/or anti-inflammatory agents.
 11. Amulti-electrode lead comprising: a plurality of electrodes; a pluralityof elongate connecting elements, each connecting element having a distalend and a proximal end, the distal end of each connecting element beingoperatively connected to one of the plurality of electrodes; a pluralityof protective sheaths, each connecting element being ensheathedseparately by at least one of the protective sheaths; and an end sheath,terminal ends of the protective sheaths extending beyond the distal endsof the connecting elements and the electrodes, the terminal ends of theprotective sheaths being bundled together within the end sheath and aresurrounded by the end sheath; wherein at least two of the connectingelements are secured together in a bundle between the distal andproximal ends, and wherein the electrodes and the distal ends of theconnecting elements are separated or readily separable such that theelectrodes are adapted to be applied to a plurality of different nerveand/or muscle tissues spaced apart across a region where multiplemuscles or multiple nerves interact region on a patient.
 12. Amulti-lead multi-electrode system, comprising: the multi-electrode leadof claim
 1. 13. The multi-lead multi-electrode system of claim 12,further comprising a ground electrode operatively connected with one ormore of the multi-electrode leads.
 14. The multi-lead multi-electrodesystem of claim 12, further comprising an operative device or aconnector, wherein one or more of the multi-electrode leads isoperatively connected at the proximate end thereof to the operativedevice or connector, and wherein the electrodes and the distal ends ofthe connectors are free for securement to one or more muscle or nervetissues.
 15. The multi-lead multi-electrode system of claim 12, furthercomprising one or more flaps attached to a coil sheath, wherein theflaps comprise a petal anchor.
 16. The multi-lead multi-electrode systemof claim 12, further comprising a coil sheath, wherein the bundle isensheathed in the coil sheath, wherein the coil sheath has an anchoringstructure, preferably at its distal end, wherein said anchoringstructure is arranged to hold the suture securing the outer sheath tocoil sheath in place.
 17. The multi-lead multi-electrode system of claim16, wherein the anchoring structure has an arrow head shape.